Suture based clamping device

ABSTRACT

Systems, assemblies, and methods are provided herein for fastening of one bone to another bone using one or more sutures. The features herein enable such fastening with a more accurate strength, and which can be more easily fastened in-situ.

CROSS-REFERENCE

This application is a continuation of International Application No.PCT/US2021/023101, filed Mar. 19, 2021, which claims the benefit of U.S.Provisional Application No. 63/002,272, filed Mar. 30, 2020, both ofwhich are hereby incorporated by reference in their entirety herein.

BACKGROUND

Several medical procedures require the fastening of one bone to anotherbone. Some such procedures include fixation of acromioclavicularseparations due to coracoclavicular ligament disruptions, fixation ofdorsal distal radioulnar ligament disruptions, stabilization of thefirst and second metatarsals for hallux valgus reconstruction, andstabilization of the first and second metacarpal when the trapezium hasbeen excised due to osteoarthritis.

SUMMARY

One aspect provided herein is a suture-button system comprising: asuture strand; a primary button having a plurality of primary aperturesand a primary threaded portion, wherein the suture strand is insertedthrough a first and second primary aperture of the plurality of primaryapertures; a secondary button having a plurality of secondary apertures,wherein the suture strand is inserted through a first and secondsecondary aperture of the plurality of secondary apertures, such that atleast one targeted tissue of a subject is clamped between a distalsurface of the primary button and a proximal surface of the secondarybutton upon applying a tension to the suture strand; and a lock having asecondary threaded portion, wherein the secondary threaded portion isremovably coupled to the primary threaded portion, wherein coupling thesecondary threaded portion of the lock to the threaded portion preventsthe suture strand from translating through the plurality of primaryapertures, thereby securing the clamping of the targeted tissue.

In some embodiments, the plurality of primary apertures comprises 2, 3,4, or 5 primary apertures. In some embodiments, the plurality of primaryapertures are equally spaced on the primary button. In some embodiments,the plurality of primary apertures are equally spaced on the primarybutton in a circular array. In some embodiments, the plurality ofprimary apertures are equally spaced on the primary button in a circulararray about the primary threaded portion. In some embodiments, theplurality of primary apertures are equally spaced on the primary buttonin a circular array about a center axis of the secondary button. In someembodiments, a proximal surface of the primary button comprises acountersink. In some embodiments, the primary threaded portion comprisesa female threaded portion. In some embodiments, the secondary threadedportion comprises a male threaded portion. In some embodiments, theprimary threaded portion comprises a male threaded portion. In someembodiments, the secondary threaded portion comprises a female threadedportion. In some embodiments, the plurality of secondary aperturescomprises 2, 3, 4, or 5 secondary apertures. In some embodiments, adistal surface of the secondary button comprises a channel connectingtwo or more of the plurality of secondary apertures. In someembodiments, one or more edges of the secondary button are rounded orchamfered. In some embodiments, an aspect ratio between the length andwidth of the secondary button is about 1:1 to about 4:1. In someembodiments, the lock comprises a head and wherein the secondarythreaded portion extends from the head. In some embodiments, a distalsurface of the head is tapered outwards from a center axis of the lock.In some embodiments, the distal surface of the head is tapered outwardsfrom a center axis of the lock by about 20° to about 89°. In someembodiments, the suture strand is a #1 size suture, a #2 size suture, a#3 size suture, a #4 size suture, a #5 size suture, a #6 size suture, ora #7 size suture. In some embodiments, the suture strand has a length ofabout 100 mm to about 1,200 mm. In some embodiments, the systemcomprises 2, 3, 4, 5, 6 or more suture strands. In some embodiments, thesystem comprises a first suture strand and a second suture strand,wherein at least a portion of the first suture strand passes within atleast a portion of the second suture strand to form a suture bundle. Insome embodiments, the portion of the first suture strand that passeswithin the second suture strand is a mesial portion of the first suture.In some embodiments, the portion of the second suture strand throughwhich the first suture strand passes is a mesial portion of the secondsuture. In some embodiments, the lock comprises a driver feature, analignment feature, or both. In some embodiments, the driver feature isopposite the secondary threaded portion. In some embodiments, the driverfeature and the alignment feature are generally concentric. In someembodiments, the driver feature is proximal to the alignment feature. Insome embodiments, a maximum inner diameter of the driver feature isgreater than a maximum inner diameter of the alignment feature. In someembodiments, the driver feature comprises a Philips driver feature, aflathead driver feature, a torx driver feature, a hex driver feature, ora square socket feature. In some embodiments, the alignment feature hasa cross sectional shape comprising a circle, a triangle, a square, apentagon, a hexagon, an octagon, or any combination thereof. In someembodiments, the system further comprises a lock driver comprising adriving feature that is configured to rotate the lock relative to theprimary button. In some embodiments, the lock driver further comprisesan aligning feature configured to align the lock driver to the alignmentfeature of the lock. In some embodiments, the alignment feature isdistal to the driving feature. In some embodiments, at least a portionof the lock extends beyond a distal face of the primary button when theprimary button is coupled to the lock. In some embodiments, a distalface of the primary button extends beyond a distal face of the lock whenthe primary button is coupled to the lock. In some embodiments, whereinat least one end of the suture strand is coupled to a terminator. Insome embodiments: the system comprises two suture strands, wherein theplurality of primary apertures comprises four primary apertures; theplurality of secondary apertures comprises two secondary apertures; afirst suture strand is inserted through a first primary aperture,through a first secondary aperture, through a second secondary aperture,and through a second primary aperture; and a second suture strand isinserted through a third primary aperture, through the first secondaryaperture, through the second secondary aperture, and through a fourthprimary aperture. In some embodiments: the system comprises two suturestrands, wherein the plurality of primary apertures comprises fourprimary apertures; the plurality of secondary apertures comprises twosecondary apertures; a first suture strand is inserted through a firstprimary aperture, through a first secondary aperture, through a secondsecondary aperture, and through a second primary aperture; and a secondsuture strand is inserted through a third primary aperture, through thesecond secondary aperture, through the first secondary aperture, andthrough a fourth primary aperture; In some embodiments, the firstprimary aperture and the second primary aperture are adjacent. In someembodiments, the first primary aperture and the second primary apertureare nonadjacent. In some embodiments, the system further comprises atightening tool comprising: a threaded rod; a knob coupled to a proximalend of the threaded rod; a collar coupled to the threaded rod; an armspinner between the knob and the collar, wherein the arm spinnercomprises an aperture accepting the threaded rod; and a handlecomprising a cavity, wherein at least a portion of the cavity comprisesa threaded feature configured to couple to the threaded rod, wherein thelock comprises the driver feature, and wherein a distal portion of thehandle comprises a tensioning feature configured to rotate the drivingfeature of the lock. In some embodiments, the arm spinner furthercomprises a terminator channel accepting the terminator. In someembodiments, the arm spinner comprises 1, 2, 3, 4, 5, 6, or moreterminator channels. In some embodiments, the knob is coupled to theproximal end of the threaded rod by a pin, an adhesive, a fastener, apress-fit, a weld, or any combination thereof. In some embodiments, thecollar is coupled to the threaded rod by a pin, an adhesive, a fastener,a press-fit, a weld, or any combination thereof. In some embodiments,the lock further comprises the alignment feature, and wherein the distalportion of the handle further comprises a tensioning alignment featurethat couples to the alignment feature. In some embodiments, the armspinner rotates freely about the threaded rod, the knob, or both. Insome embodiments, rotating the knob and the threaded rod in a firstdirection with respect with to the handle translates the spinnerproximally from the handle. In some embodiments, rotating the knob andthe threaded rod in a second direction opposite the first directiontranslates the spinner distally to the handle. In some embodiments,rotating the handle in a first direction tightens the lock against theprimary button.

Another aspect provided herein is a suture-button system comprising: oneor more a suture strands; a primary button having a plurality of primaryapertures, and a primary threaded portion; a secondary button having aplurality of secondary apertures; and a lock having a secondary threadedportion, wherein the secondary threaded portion is removably coupled tothe primary threaded portion; wherein each primary aperture has one ormore of the plurality of sutures strands inserted therethrough, whereineach secondary aperture has one or more of the plurality of suturesstrands inserted therethrough, and wherein coupling the secondarythreaded portion of the lock to the threaded portion prevents each ofthe plurality of suture strands from translating through one or more ofthe plurality of first button apertures. In some embodiments, theplurality of primary apertures comprises 2, 3, 4, or 5 primaryapertures. In some embodiments, the plurality of primary apertures areequally spaced on the primary button. In some embodiments, the pluralityof primary apertures are equally spaced on the primary button in acircular array. In some embodiments, the plurality of primary aperturesare equally spaced on the primary button in a circular array about theprimary threaded portion. In some embodiments, the plurality of primaryapertures are equally spaced on the primary button in a circular arrayabout a center axis of the secondary button. In some embodiments, aproximal surface of the primary button comprises a countersink. In someembodiments, the primary threaded portion comprises a female threadedportion. In some embodiments, the secondary threaded portion comprises amale threaded portion. In some embodiments, the primary threaded portioncomprises a male threaded portion. In some embodiments, the secondarythreaded portion comprises a female threaded portion. In someembodiments, the plurality of secondary apertures comprises 2, 3, 4, or5 secondary apertures. In some embodiments, a distal surface of thesecondary button comprises a channel connecting two or more of theplurality of secondary apertures. In some embodiments, one or more edgesof the secondary button are rounded or chamfered. In some embodiments,an aspect ratio between the length and width of the secondary button isabout 1:1 so about 4:1. In some embodiments, the lock comprises a headand wherein the secondary threaded portion extends from the head. Insome embodiments, a distal surface of the head is tapered outwards froma center axis of the lock. In some embodiments, the distal surface ofthe head is tapered outwards from a center of the lock by about 20° toabout 89°. In some embodiments, the lock comprises a driver feature, analignment feature, or both. In some embodiments, the driver feature isopposite the secondary threaded portion. In some embodiments, the driverfeature and the alignment feature are generally concentric. In someembodiments, the driver feature is proximal to the alignment feature. Insome embodiments, a maximum inner diameter of the driver feature isgreater than a maximum inner diameter of the alignment feature. In someembodiments, the driver feature comprises a Philips driver feature, aflathead driver feature, a torx driver feature, a hex driver feature, ora square socket feature. In some embodiments, the alignment feature hasa cross sectional shape comprising a circle, a triangle, a square, apentagon, a hexagon, an octagon, or any combination thereof. In someembodiments, they system further comprises a lock driver comprising adriving feature that is configured to rotate the lock about the primarybutton. In some embodiments, the lock driver further comprises analigning feature configured to align the lock driver to the alignmentfeature of the lock. In some embodiments, the alignment feature isdistal to the driving feature. In some embodiments, at least a portionof the lock extends beyond a distal face of the primary button when theprimary button is coupled to the lock. In some embodiments, a distalface of the primary button extends beyond a distal face of the lock whenthe primary button is coupled to the lock. In some embodiments: theplurality of primary apertures comprises two primary apertures; theplurality of secondary apertures comprises two secondary apertures; theone or more suture strands consists of one suture strand; and the onesuture strand is inserted through a first primary aperture, through afirst secondary aperture, through a second secondary aperture, andthrough a second primary aperture. In some embodiments: the plurality ofprimary apertures comprises four primary apertures; the plurality ofsecondary apertures comprises two secondary apertures; the one or more asuture strands consists of two suture strands; a first suture strand isinserted through a first primary aperture, through a first secondaryaperture, through a second secondary aperture, and through a secondprimary aperture; and a second suture strand is inserted through a thirdprimary aperture, through the first secondary aperture, through thesecond secondary aperture, and through a fourth primary aperture; Insome embodiments: the plurality of primary apertures comprises fourprimary apertures; the plurality of secondary apertures comprises twosecondary apertures; the one or more a suture strands consists of twosuture strands; a first suture strand is inserted through a firstprimary aperture, through a first secondary aperture, through a secondsecondary aperture, and through a second primary aperture; and a secondsuture strand is inserted through a third primary aperture, through thesecond secondary aperture, through the first secondary aperture, andthrough a fourth primary aperture; In some embodiments, the firstprimary aperture and the second primary aperture are adjacent. In someembodiments, the first primary aperture and the second primary apertureare nonadjacent. In some embodiments, the system further comprises atightening tool comprising: a threaded rod; a knob coupled to a proximalend of the threaded rod; a collar coupled to the threaded rod; an armspinner between the knob and the tensioning collar, wherein the armspinner comprises an aperture accepting the threaded rod; and a handlecomprising a cavity, wherein at least a portion of the cavity comprisesa threaded feature configured to couple to the threaded rod, wherein thelock comprises the driver feature, and wherein a distal portion of thehandle comprises a tensioning feature configured to rotate the drivingfeature of the lock. In some embodiments, the arm spinner furthercomprises a terminator channel accepting the terminator. In someembodiments, the arm spinner comprises 1, 2, 3, 4, 5, 6, or moreterminator channels. In some embodiments, the knob is coupled to theproximal end of the threaded rod by a pin, an adhesive, a fastener, apress-fit, a weld, or any combination thereof. In some embodiments, thecollar is coupled to the threaded rod by a pin, an adhesive, a fastener,a press-fit, a weld, or any combination thereof. In some embodiments,the lock further comprises the alignment feature, and wherein the distalportion of the handle further comprises a tensioning alignment featurethat couples to the alignment feature. In some embodiments, the armspinner rotates freely about the threaded rod, the knob, or both. Insome embodiments, rotating the knob and the threaded rod in a firstdirection with respect with to the handle translates the spinnerproximally from the handle. In some embodiments, rotating the knob andthe threaded rod in a second direction opposite the first directiontranslates the spinner distally towards the handle. In some embodiments,rotating the handle in a first direction tightens the lock against theprimary button. In some embodiments, the suture is a #1 size suture, a#2 size suture, a #3 size suture, a #4 size suture, a #5 size suture, a#6 size suture, or a #7 size suture. In some embodiments, the suture hasa length of about 100 mm to about 1,200 mm. In some embodiments, thesystem comprise 2, 3, 4, 5, 6 or more suture strands. In someembodiments, the system comprise a first suture strand and a secondsuture strand, wherein at least a portion of the first suture strandpasses within at least a portion of the second suture strand to form asuture bundle 170. In some embodiments, the portion of the first suturestrand that passes within the second suture strand is a mesial portionof the first suture. In some embodiments, the portion of the secondsuture strand through which the first suture strand passes is a mesialportion of the second suture.

Another aspect provided herein is a suture-button assembly comprising:two or more suture-button systems; and an insertion plate comprising aplurality of insertion plate apertures, each insertion plate apertureaccepting at least one suture strand. In some embodiments, the pluralityof insertion plate apertures comprises 2, 3, 4, 5, 6, or more insertionplate apertures. In some embodiments, the assembly further comprises aninsertion screw, wherein the insertion plate further comprises a screwhole; configured to removable couple to the insertion screw. In someembodiments, the screw hole is positioned between two of the pluralityof insertion plate apertures. In some embodiments, the insertion screwcomprises a first portion configured to removably couple to the screwhole and a second portion configured to attach to a bone of a patient.

Another aspect provided herein is a method of assembling a suturebutton, the method comprising: providing the suture-button system of anyone or more embodiments described herein, wherein: the plurality ofprimary apertures comprises a first primary aperture and a secondprimary aperture; the plurality of secondary apertures comprises a firstsecondary aperture and a second secondary aperture; and the one or morea suture strands consists of one suture strand; inserting the one suturestrand through the first primary aperture; inserting the one suturestrand through the first secondary aperture; inserting the one suturestrand through the second secondary aperture; and inserting the onesuture strand through the second primary aperture. In some embodiments,the method further comprises inserting the secondary button through ahole in a bone or tissue. In some embodiments, the method furthercomprises rotating the secondary button after its insertion through thehole in the bone or tissue such that a proximal face of the secondarybutton lies against the bone or tissue. In some embodiments, the methodfurther comprises coupling the secondary threaded portion of the lockwith the primary threaded portion of the primary button to prevent thesuture strand from translating through the first primary aperture andthe second primary aperture. In some embodiments, the method furthercomprises providing the tightening tool of any one or more embodimentsdescribed herein. In some embodiments, the secondary threaded portionand the primary threaded portion are coupled by the tightening tool. Insome embodiments, the method further comprises tightening the suturestrand with respect to the primary button, the secondary button, orboth, with the tightening tool.

Another aspect provided herein is a method of assembling a suturebutton, the method comprising: providing the suture-button system of anyone or more embodiments described herein, wherein: the plurality ofprimary apertures comprises a first primary aperture, a second primaryaperture, a third primary aperture, and a fourth primary aperture; theplurality of secondary apertures comprises a first secondary apertureand a second secondary aperture; and the one or more a suture strandsconsists of a first suture strand and a second suture strand; insertingthe first suture strand through the first primary aperture; insertingthe first suture strand through the first secondary aperture; insertingthe first suture strand through the second secondary aperture; insertingthe first suture strand through the second primary aperture; insertingthe second suture strand through the third primary aperture; insertingthe second suture strand through the first secondary aperture; insertingthe second suture strand through the second secondary aperture; andinserting the second suture strand through the fourth primary aperture.In some embodiments, the method further comprises inserting thesecondary button through a hole in a bone or tissue. In someembodiments, the method further comprises rotating the secondary buttonafter its insertion through the hole in the bone or tissue such that aproximal face of the secondary button lies against the bone or tissue.In some embodiments, the method further comprises coupling the secondarythreaded portion of the lock with the primary threaded portion of theprimary button to prevent the first suture strand and the second suturestrand from translating through the plurality of primary apertures. Insome embodiments, the method further comprises providing the tighteningtool of any one or more embodiments described herein. In someembodiments, the secondary threaded portion and the primary threadedportion are coupled by the tightening tool. In some embodiments, themethod further comprises tightening the first suture strand and thesecond suture strand with respect to the primary button, the secondarybutton, or both, with the tightening tool.

Another aspect provided herein is a method of assembling a suturebutton, the method comprising: providing the suture-button system of anyone or more embodiments described herein, wherein: the plurality ofprimary apertures comprises a first primary aperture, a second primaryaperture, a third primary aperture, and a fourth primary aperture; theplurality of secondary apertures comprises a first secondary apertureand a second secondary aperture; and the one or more a suture strandsconsists of a first suture strand and a second suture strand; insertingthe first suture strand through the first primary aperture; insertingthe first suture strand through the first secondary aperture; insertingthe first suture strand through the second secondary aperture; insertingthe first suture strand through the second primary aperture; insertingthe second suture strand through the third primary aperture; insertingthe second suture strand through the second secondary aperture;inserting the second suture strand through the first secondary aperture;and inserting the second suture strand through the fourth primaryaperture. In some embodiments, the method further comprises insertingthe secondary button through a hole in a bone or tissue. In someembodiments, the method further comprises rotating the secondary buttonafter its insertion through the hole in the bone or tissue such that aproximal face of the secondary button lies against the bone or tissue.In some embodiments, the method further comprises coupling the secondarythreaded portion of the lock with the primary threaded portion of theprimary button to prevent the first suture strand and the second suturestrand from translating through the plurality of primary apertures. Insome embodiments, the method further comprises providing the tighteningtool of any one or more embodiments described herein. In someembodiments, the secondary threaded portion and the primary threadedportion are coupled by the tightening tool. In some embodiments, themethod further comprises tightening the first suture strand and thesecond suture strand with respect to the primary button, the secondarybutton, or both, with the tightening tool.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the disclosure are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present disclosure will be obtained by reference tothe following detailed description that sets forth illustrativeembodiments, in which the principles of the disclosure are utilized, andthe accompanying drawings of which:

FIG. 1 shows a front-view illustration of an exemplary suture-buttonassembly, per an embodiment herein;

FIG. 2 shows a right-side-view illustration of an exemplarysuture-button assembly, per an embodiment herein;

FIG. 3 shows a top-view illustration of an exemplary suture-buttonassembly, per an embodiment herein;

FIG. 4 shows a bottom-view illustration of an exemplary suture-buttonassembly, per an embodiment herein;

FIG. 5 shows a perspective illustration of an exemplary primary button,per an embodiment herein;

FIG. 6A shows a bottom-view illustration of an exemplary primary button,per an embodiment herein;

FIG. 6B shows a first cross-sectional illustration of an exemplaryprimary button, per an embodiment herein;

FIG. 6C shows a second cross-sectional illustration of an exemplaryprimary button, per an embodiment herein;

FIG. 7A shows a perspective illustration of an exemplary lock, per anembodiment herein;

FIG. 7B shows a top-view illustration of an exemplary lock, per anembodiment herein;

FIG. 7C shows a cross-sectional illustration of an exemplary lock, peran embodiment herein;

FIG. 7D shows a side view illustration of an exemplary lock, per anembodiment herein;

FIG. 8 shows a cross-sectional illustration of an exemplary lock coupledto an exemplary primary button, per an embodiment herein;

FIG. 9A shows a perspective illustration of an exemplary secondarybutton, per an embodiment herein;

FIG. 9B shows a bottom-view illustration of an exemplary secondarybutton, per an embodiment herein;

FIG. 9C shows a cross-sectional illustration of an exemplary secondarybutton, per an embodiment herein;

FIG. 10A shows a perspective illustration of an exemplary bundle 170 ofsutures, per an embodiment herein;

FIG. 10B shows a cross-sectioned illustration of an exemplary bundle 170of sutures, per an embodiment herein;

FIG. 11A shows a perspective illustration of an exemplary suture-buttonassembly with a first suture loop, per an embodiment herein;

FIG. 11B shows a perspective illustration of an exemplary suture-buttonassembly with a first suture loop and a second suture loop, per anembodiment herein;

FIG. 12 shows an illustration of an exemplary suture-button assemblywith a first suture loop and a second suture loop, per an embodimentherein;

FIG. 13 shows a top-view illustration of an exemplary suture-buttonassembly with an insertion needle 220 device, per an embodiment herein;

FIG. 14A shows a perspective illustration of an exemplary suture-buttonassembly with an exemplary lock driver, per an embodiment herein;

FIG. 14B shows a perspective illustration of an exemplary suture-buttonassembly with an exemplary lock driver and an exemplary insertion plate,per an embodiment herein;

FIG. 15A shows a perspective illustration of an exemplary lock driver,per an embodiment herein;

FIG. 15B shows a front-view illustration of an exemplary lock driver,per an embodiment herein;

FIG. 16A shows a detailed perspective illustration of an exemplary lockdriver, per an embodiment herein;

FIG. 16B shows a bottom-view illustration of an exemplary lock driver,per an embodiment;

FIG. 17A shows a detailed perspective illustration of the drivingfeature of an exemplary lock driver rotating the lock, per an embodimentherein;

FIG. 17B shows a front cross-sectioned illustration of the drivingfeature and the aligning feature of an exemplary lock driver rotatingthe lock, per an embodiment herein;

FIG. 17C shows a first front cross-sectioned illustration of the drivingfeature and the aligning feature of an exemplary lock driver rotatingthe lock, per an embodiment herein;

FIG. 17D shows a second front cross-sectioned illustration of thedriving feature and the aligning feature of an exemplary lock driverrotating the lock, per an embodiment herein;

FIG. 18 shows a front-view illustration of an exemplary suture-buttonsystem having a tightening tool, per an embodiment;

FIG. 19A shows a front-view illustration of an exemplary tightening toolin a collapsed position, per an embodiment herein;

FIG. 19B shows a front cross-sectioned illustration of an exemplarytightening tool in the collapsed position, per an embodiment herein;

FIG. 19C shows a front-view illustration of an exemplary tightening toolin an expanded position, per an embodiment herein;

FIG. 20 shows a top-view illustration of an exemplary tightening tool,per an embodiment herein;

FIG. 21 shows a perspective exploded illustration of an exemplarytightening tool, per an embodiment herein;

FIG. 22A shows a detailed bottom-left-front perspective illustration ofa tensioning feature and an alignment feature of an exemplary tighteningtool, per an embodiment herein;

FIG. 22B shows a detailed top-right-front illustration of an exemplarytightening tool engaged with an exemplary lock, per an embodimentherein;

FIG. 22C shows a cross-section illustration of an exemplary tighteningtool engaging with the lock, per an embodiment herein;

FIG. 23 shows a front-view illustration of an exemplary suture-buttonassembly comprising two suture-button systems and an insertion plate,per an embodiment herein;

FIG. 24 shows a perspective illustration of an exemplary insertion platecoupled to an exemplary insertion screw, per an embodiment herein;

FIG. 25A shows a perspective illustration of the exemplary insertionplate, per an embodiment herein;

FIG. 25B shows a detailed top-right-front illustration of the exemplaryinsertion plate, per an embodiment herein;

FIG. 25C shows a cross-section illustration of the exemplary insertionplate, per an embodiment herein;

FIG. 26A shows a perspective illustration of an insertion screw, per anembodiment herein;

FIG. 26B shows a front-view illustration of an insertion screw, per anembodiment herein;

FIG. 27A shows a perspective illustration of inserting a suture strandthrough a first primary aperture of the primary button, per anembodiment herein;

FIG. 27B shows a perspective illustration of inserting a suture strandthrough a first and second secondary aperture of the secondary button,per an embodiment herein;

FIG. 27C shows a perspective illustration of inserting a suture strandthrough a second primary aperture of the primary button, per anembodiment herein;

FIG. 28A shows a cross-section illustration of inserting a suture strandthrough a first primary aperture of the primary button, per anembodiment herein;

FIG. 28B shows a perspective illustration of inserting a suture strandthrough a first secondary aperture and a second secondary aperture ofthe secondary button, per an embodiment herein;

FIG. 28C shows a perspective illustration of inserting a suture strandthrough a first primary aperture of the primary button, per anembodiment herein;

FIG. 28D shows a perspective illustration of inserting a suture strandthrough a second primary aperture of the primary button, per anembodiment herein;

FIG. 29A shows a cross-section illustration of inserting a first andsecond suture strand through the respective apertures of the primarybutton, per an embodiment herein; and

FIG. 29B shows a perspective illustration of a lock securing a first andsecond suture strand inserted through the respective apertures of theprimary button, per an embodiment herein.

DETAILED DESCRIPTION

Potential applications of the devices, systems, and methods hereininclude but are not limited to fixation of acromioclavicular separationsdue to coracoclavicular ligament disruptions, fixation of dorsal distalradioulnar ligament disruptions, stabilization of the first and secondmetatarsals for hallux valgus reconstruction, and stabilization of thefirst and second metacarpal when the trapezium has been excised due toosteoarthritis.

Suture-Button Systems

One aspect provided herein per FIGS. 1-13B is a suture-button system100. In some embodiments, the suture-button system comprises one or moresuture strands 130, a primary button 110, a secondary button 120, and alock 140. In some embodiments, the lock 140 couples to the primarybutton 110.

In some embodiments, the suture strand 130 is a standard suture. In someembodiments, the suture strand 130 is a medical grade suture. In someembodiments, the suture is a #1 size suture, a #2 size suture, a #3 sizesuture, a #4 size suture, a #5 size suture, a #6 size suture, or a #7size suture. In some embodiments, the suture strand 130 has a length ofabout 100 mm to about 1,200 mm. In some embodiments, the system 100comprises 2, 3, 4, 5, 6 or more suture strands 130. As disclosed herein,the terms suture and suture strands are used interchangeably.

In some embodiments, per FIGS. 1-4, and 10A-13, the system 100 comprisesa first suture strand 130 and a second suture strand 130. In someembodiments, the first suture strand 130 and the second suture strand130 are bundled 170 together. In some embodiments, per FIGS. 10A and10B, at least a portion of the second suture strand 130 is hollow orcomprises a channel, wherein at least a portion of the first suturestrand 130 passes within at least a portion of the hollow portion or thechannel of the second suture strand 130 to form a suture bundle 170. Insome embodiments, the portion of the first suture strand 130 that passeswithin the second suture strand 130 is a mesial portion of the firstsuture. In some embodiments, the portion of the second suture strand 130through which the first suture strand 130 passes is a mesial portion ofthe second suture. Alternatively, in some embodiments, the system 100comprises three or more suture strands 130, wherein one or more of thethree or more suture strands 130 are bundled 170 together. In someembodiments, bundling the suture strands 130 together reduces frayingupon contact and/or movement with respect to the secondary button 120.In some embodiments, one or two of the three or more suture strands 130pass within one or two other passes within at least a portion of anothersuture strand 130.

In some embodiments, per FIGS. 11A-13, two ends of a suture strand 130are coupled to each other. Further, in some embodiments two ends of asuture strand 130 are coupled to each other to form a suture loop 132.In some embodiments, two ends of a suture strand 130 are tied togetherin a knot to form a suture loop. In some embodiments, per FIG. 12, twoends of a suture strand 130 are coupled to each other by a terminator131. In some embodiments, at least one end of a suture strand 130 iscoupled to the terminator 131. In some embodiments, both ends of asuture strand is coupled to a terminator 131. In some embodiments, theterminator is coupled to both ends of the suture to form a suture loop132. In some embodiments, the terminator 131 is coupled to both ends ofeach of two sutures to form two suture loops 132. In some embodiments,the terminator 131 is coupled to the suture by a crimp, a fastener, anadhesive, a tie, or any combination thereof. In some embodiments, anouter diameter of the terminator 131 is greater than twice an outerdiameter of the suture strands 130. In some embodiments, the sutureloops 132 ease hand tensioning.

In some embodiments, tension applied to one or more suture loops adjuststhe distance between the primary and secondary buttons. In someembodiments, tension applied to one or more suture loops brings theprimary and secondary buttons closer together. In some embodiments,tension applied to one or more suture loops provides a clamping pressureor force about a bone or tissue located between the primary andsecondary buttons. In some embodiments, tension is applied by tighteningthe one or more suture loops. In some embodiments, the one or moresuture loops are tightened by pulling on the one or more suture loops.In some embodiments, the one or more suture loops are pulled in aproximal direction relative to the primary button.

In some embodiments, per FIGS. 5 and 6, the primary button 110 comprisesfour primary apertures 111 and a primary threaded portion 112.Alternatively, in some embodiments, the primary button 110 comprises 2,3, 5, 6, or more primary apertures 111. Further, per FIGS. 5 and 6, thefour primary apertures 111 are equally spaced apart on the primarybutton 110 in a circular array about the primary threaded portion 112and/or about a center axis of the secondary button 120. As shown, theprimary apertures 111 are circular. Alternatively, the primary apertures111 are oblong or polygonal.

In some embodiments, per FIGS. 5, 6C, and 8, a proximal surface 113 ofthe primary button 110 is tapered towards the primary threaded portion112. In some embodiments, per FIG. 6C, the proximal surface 113 of theprimary button 110 is tapered at an angle of about 30°, about 35°, about40°, about 45°, about 50°, about 55°, about 60°, about 65°, about 70°,about 75°, about 80°, or about 85° relative to a central axis 115concentric to the primary threaded portion 112. In some embodiments, theproximal surface 113 of the primary button 110 is tapered at an angle ofabout 30 to about 85°, including increments therein, relative to acentral axis 115 concentric to the primary threaded portion. In someembodiments, the primary button proximal surface 113 is tapered at anangle of about 20° to about 89° relative to the central axis through theprimary threaded portion.

As shown in FIGS. 5, 6A-C, and 8, the primary threaded portion 112comprises a female threaded portion. Further as shown, the primarythreaded portion 112 is centered within the proximal surface 113 of theprimary button 110. Alternatively, in some embodiments, the primarythreaded portion 112 comprises a male threaded portion. In someembodiments, the primary threaded portion 112 comprises a straightthreaded portion. In some embodiments, the primary threaded portion 112comprises a tapered threaded portion. In some embodiments, the primarythreaded portion 112 comprises a machine threaded portion. In someembodiments, the primary threaded portion 112 comprises a pipe threadedportion.

In some embodiments, one or more outer edges of the primary button 110are rounded or chamfered. In some embodiments, one or more edges of theapertures 111 on a distal face of the primary button 110 are rounded orchamfered. In some embodiments, one or more edges of the primaryapertures 111 on a proximal face of the primary button 110 are roundedor chamfered. In some embodiments, one or more edges of the primarybutton 110 are rounded or chamfered. In some embodiments, the rounded orchamfered edges reduce and/or prevent damage to a portion of suturestrand 130 passing thereover.

As shown in FIGS. 9A-C, the secondary button 120 comprises a firstsecondary aperture 121 and a second secondary aperture 121.Alternatively, in some embodiments, the plurality of secondary apertures121 comprises 3, 4, 5, 6, or more secondary apertures 121. As shown, thesecondary apertures 121 are oblong. Alternatively, the secondaryapertures 121 are circular or polygonal. In some embodiments, eachsecondary aperture 121 accepts one or more suture strands 130therethrough. In some embodiments, each secondary aperture 121 accepts1, 2, 3, 4, 5, 6 or more suture strands 130 therethrough. In someembodiments, per FIGS. 9B-C, a distal surface of the secondary button120 comprises a channel 122 connecting two or more of the plurality ofsecondary apertures 121. As seen the channel 122 has a width equal to aninner width of the first secondary aperture 121, the second secondaryaperture 121, or both. In some embodiments, the channel 122 has a depth122A of about 25% to about 75% of the thickness 120C of the secondarybutton 120. In some embodiments, an aspect ratio between the length 120Aand width 120B of the secondary button 120 is about 1:1 to about 4:1. Insome embodiments, the aspect ratio and/or thickness 120C of thesecondary button 120 enables its insertion through a narrow cavity in abone.

In some embodiments, the primary button 110 has a width of about 3 mm toabout 12 mm. In some embodiments, the primary button 110 has a length ofabout 3 mm to about 12 mm. In some embodiments, the primary button 110has a diameter of about 3 mm to about 12 mm. In some embodiments, theprimary button 110 has a thickness of about 0.5 mm to about 3 mm. Insome embodiments, the secondary button 120 has a width of about 2 mm toabout 7 mm. In some embodiments, the secondary button 120 has a lengthof about 7 mm to about 20 mm. In some embodiments, the secondary button120 has a thickness of about 0.5 mm to about 3 mm.

Further per FIG. 9C, in some embodiments, one or more edges of thesecondary button 120 are rounded or chamfered. In some embodiments, oneor more outer edges of the secondary button 120 are rounded orchamfered. In some embodiments, one or more edges of the secondaryapertures 121, the channel 122, or both are rounded or chamfered. Insome embodiments, one or more edges of the secondary apertures 121 on adistal face of the secondary button 120 are rounded or chamfered. Insome embodiments, one or more edges of the secondary apertures 121 on aproximal face of the secondary button 120 are rounded or chamfered. Insome embodiments, the rounded or chamfered edges reduce and/or preventdamage to a portion of suture passing thereover.

In some embodiments, a distance between the centers 121A, 121B of afirst secondary aperture 121 and a second secondary aperture 121 isgreater than a distance between the centers of at least one pair ofopposing primary apertures 111. In some embodiments, a distance betweenthe centers 121A, 121B of the first secondary aperture 121 and thesecond secondary aperture 121 is less than a distance between thecenters of at least one pair of opposing primary apertures 111. In someembodiments, a distance between the centers 121A, 121B of the firstsecondary aperture 121 and the second secondary aperture 121 is equal toa distance between the centers of at least one pair of opposing primaryapertures 111. In some embodiments, a distance between the centers 121A,121B of the first secondary aperture 121 and the second secondaryaperture 121 is greater than a distance between the centers of at leastone pair of adjacent primary apertures 111. In some embodiments, adistance between the centers 121A, 121B of the first secondary aperture121 and the second secondary aperture 121 is less than a distancebetween the centers of at least one pair of adjacent primary apertures111. In some embodiments, a distance between the centers 121A, 121B ofthe first secondary aperture 121 and the second secondary aperture 121is equal to a distance between the centers of at least one pair ofadjacent primary apertures 111.

Per FIGS. 7A-D, the lock 140 comprises a secondary threaded portion 141and a head 144, wherein the secondary threaded portion 141 extends fromthe head 144. As shown, the secondary threaded portion 141 comprises amale threaded portion. Alternatively, in some embodiments, the secondarythreaded portion 141 comprises a female threaded portion. In someembodiments, the secondary threaded portion 141 comprises a straightthreaded portion. In some embodiments, the secondary threaded portion141 comprises a tapered threaded portion. In some embodiments, thesecondary threaded portion 141 comprises a machine threaded portion. Insome embodiments, the secondary threaded portion 141 comprises a pipethreaded portion. In some embodiments, the lock 140 comprises a driverfeature 142, an alignment feature 143, or both. In some embodiments, thedriver feature is disposed at least partially within the head 144. Insome embodiments, the driver feature 142 is opposite the secondarythreaded portion 141. In some embodiments, the driver feature 142 andthe alignment feature 143 are generally concentric. In some embodiments,the driver feature 142 is proximal to the alignment feature 143. In someembodiments, a maximum inner diameter of the driver feature 142 isgreater than a maximum inner diameter of the alignment feature 143. Insome embodiments, the driver feature comprises a Philips driver feature,a flathead driver feature, a torx driver feature, a hex driver feature,or a square socket feature. In some embodiments, the alignment feature143 has a cross sectional shape comprising a circle, a triangle, asquare, a pentagon, a hexagon, an octagon, or any combination thereof.In some embodiments, a proximal edge of the alignment feature 143 isrounded or chamfered.

As shown per FIGS. 7C, 7D, and 8, a distal surface 145 of the head 144is tapered towards the secondary threaded portion 141. In someembodiments, a distal surface 145 of the head 144 is tapered inward tothe center axis 146 of the lock 140. In some embodiments, the distalsurface 145 of the head 144 is tapered outwards from the center axis 146of the lock 140 at an angle of about 20° to about 89° relative to anaxis parallel the center axis 146 of the lock 140.

In some embodiments, per FIG. 8, the secondary threaded portion 141 isconfigured to be removably coupled to the primary threaded portion 112.In some embodiments, coupling the secondary threaded portion 141 of thelock 140 to the primary threaded portion 112 of the primary button 110prevents the suture strand 130 from translating through one or more ofthe plurality of first button apertures.

Further per FIG. 8, at least a portion of the tapered distal face 145 oflock 140 seats against the tapered portion of the primary buttonproximal surface 113 of the primary button 110. In some embodiments, theangle that the distal face of the lock 140 tapers is equivalent to anangle that the primary button proximal face 113 tapers towards theprimary threaded portion. In some embodiments, the angle between theproximal surface 113 of the primary button 110 relative to its centralaxis 115, and the angle between the distal surface 145 of the head 144relative to the center axis 146 of the lock 140 are complementary. Insome embodiments, the angle between the proximal surface 113 of theprimary button 110 relative to its central axis 115, and the anglebetween the distal surface 145 of the head 144 relative to the centeraxis 146 of the lock 140 are equal. In some embodiments, at least aportion of the distal surface 145 of the head 144, the proximal surface113 of the primary button 110, or both have a texture configured toincrease friction against the suture strand 130.

In some embodiments of a first suture-button system 100A, per FIG. 11A,the primary button comprises a first primary aperture and a secondprimary aperture, the secondary button comprises a first secondaryaperture and a second secondary aperture, and a single suture strandpasses through the apertures of the primary and secondary buttons. Insome embodiments of a second suture-button system 100, per FIGS. 1, 2,3, 11B and 12, the primary button comprises a first primary aperture, asecond primary aperture, a third primary aperture, and a fourth primaryaperture, the secondary button comprises a first secondary aperture anda second secondary aperture, and a first suture strand and a secondsuture strand pass through one or more apertures of the primary andsecondary buttons.

Per FIGS. 1, 2, and 3, for the second suture button assembly, eachprimary aperture 111 of the primary button has one suture strand 130inserted therethrough. Alternatively, in some embodiments, each primaryaperture 111 has two or more of the plurality of suture strands insertedtherethrough. In some embodiments, each primary aperture 111 has 2, 3,4, 5, 6 or more suture strands inserted therethrough. In someembodiments, each secondary aperture 121 has one or more of theplurality of suture strands inserted therethrough. Per FIGS. 1, 2 and 4,each secondary aperture 121 has two suture strands 130 insertedtherethrough. As shown, each secondary aperture 121 has one suturestrand 130 inserted distally and one suture strand 130 insertedproximally therethrough. Alternatively, each secondary aperture 121 hastwo suture strands 130 inserted distally therethrough. Alternatively,each secondary aperture 121 has two suture strands 130 insertedproximally therethrough. Alternatively, in some embodiments, eachsecondary aperture 121 has three or more sutures strands 130 insertedtherethrough. In some embodiments, each secondary aperture 121 has 2, 3,4, 5, 6 or more sutures strands 130 inserted therethrough.

Per FIG. 3, once the plurality of suture strands has been insertedthrough the apertures of the primary and secondary buttons, coupling thelock 140 to the primary button 110 prevents each of the plurality ofsuture strands 130 from translating through one or more of the pluralityof primary apertures 111. In some embodiments, coupling the lock 140 tothe primary threaded portion 141 prevents each of the plurality ofsuture strands 130 from translating through one or more of the pluralityof primary apertures by compressing at least a portion of each of theplurality of suture strands 130 between the distal face 145 of the lock140 and the primary button proximal face 113.

In some embodiments, rotating the lock 140 in a first direction relativeto the primary button inserts the secondary threaded portion 141 of thelock 140 distally through the primary threaded portion 113 of theprimary button 110, so as to compress at least a portion of each of theplurality of suture strands 130 located between the distal face 145 ofthe head 144 and the primary button proximal face 113. In someembodiments, rotating the lock 140 in a second direction relative to theprimary button, opposite the first direction, translates the secondarythreaded portion 141 of the lock 140 proximally through the primarythreaded portion 113 of the primary button 110, so as to enable each ofthe plurality of suture strands 130 to translate through the pluralityof primary apertures 111.

In some embodiments, per FIG. 8, at least a portion of the lock 140extends beyond a distal face of the primary button 110 when the primarybutton 110 is coupled to the lock 140. In some embodiments, a distalface of the primary button 110 extends beyond a distal end of thesecondary threaded portion 141 of the lock 140 when the primary button110 is coupled to the lock 140. In some embodiments, at least a portionof the lock 140 extends beyond a distal face of the primary button 110by an extension distance 147 of about 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6mm, 7 mm, 8 mm, 9 mm, 10 mm, or more when the primary button 110 iscoupled to the lock 140. In some embodiments, a distal face of theprimary button 110 extends beyond a distal end of the secondary threadedportion 141 of the lock 140 by an extension distance of about 1 mm, 2mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, or more when theprimary button 110 is coupled to the lock 140. In some embodiments, atleast a portion of the lock 140 extends beyond a distal face of theprimary button 110 into a bone or tissue. In some embodiments, at leasta portion of the lock 140 extends beyond a distal face of the primarybutton 110 into a bone or tissue tunnel or hole. In some embodiments, atleast a portion of the lock 140 extends beyond a distal face of theprimary button 110 into a bone or tissue tunnel or hole when the primarybutton 110 is in contact with the bone or tissue tunnel.

In some embodiments, per FIG. 13, the system 100 further comprises aninsertion suture 210, an insertion needle 220, or both. In someembodiments, the secondary button 120 is attached to the insertionneedle 220 via an insertion suture 210. In some embodiments, theinsertion needle 220 is configured to be inserted through a hole in atargeted tissue, which then pulls the secondary button 120 therethroughvia the insertion suture 210. In some embodiments, pulling the secondarybutton 120 through the hole in the targeted tissue also pulls the one ormore suture strands 130 that is coupled to the secondary button throughsaid hole. In some embodiments, the insertion needle 220 is thendisconnected from the secondary button 120 by cutting and removing theinsertion suture 210.

In some embodiments, per FIGS. 14A-17D, the system 100 further comprisesa lock driver device 180. In some embodiments, the lock driver 180comprises a driving feature 182 that is configured to rotate the lock140 relative to the primary button 110. In some embodiments, the drivingfeature 182 is a male driving feature wherein the driver feature 142 ofthe lock 140 is a female driver feature. In some embodiments, thedriving feature 182 is a female driving feature wherein the driverfeature 142 of the lock 140 is a male driver feature. In someembodiments, at least a portion of the driver feature 142 fits within aportion of the driving feature 182. In some embodiments, at least aportion of the driving feature 182 fits within a portion of the driverfeature 142. In some embodiments, the lock driver 180 further comprisesan aligning feature 183 configured to align the lock driver 180 to thealignment feature 143 of the lock 140. In some embodiments, the aligningfeature 183 is configured to align the lock driver 180 to the alignmentfeature 143 of the lock 140 while the lock driver 180 rotates the lock140 relative to the primary button 110. In some embodiments, rotatingthe lock driver 180 in a first direction inserts the secondary threadedportion 141 of the lock 140 distally through the primary threadedportion 113 of the primary button 110. In some embodiments, rotating thelock driver 180 in a second direction opposite the first directiontranslates the secondary threaded portion 141 of the lock 140 proximallythrough the primary threaded portion 113 of the primary button 110. Insome embodiments, the alignment feature 183 is distal to the drivingfeature 182. In some embodiments, a maximum outer diameter of thealignment feature 183 is less than a maximum outer diameter of thedriving feature 182. As shown, the driver feature 142 comprise a torxdriver feature, Alternatively, in some embodiments, the driver feature142 comprises a Philips driver feature 142, a flathead driver feature142, a hex driver feature 142, or a square socket feature. In someembodiments, the lock driver 180 enables a greater tightening force thancan be applied by hand. In some embodiments, the lock driver 180 enablesa more precise and tunable tightening force than can be applied by hand.

In some embodiments, per FIGS. 18-22C, the system 100 further comprisesa tightening tool 190. In some embodiments, the tightening tool 190comprises: a threaded rod 194; a knob 191; a spinner 192, a collar 196,and a handle 193. In some embodiments, the knob 191 is coupled to thethreaded rod 194. In some embodiments, the knob 191 is permanentlycoupled to the threaded rod 194. In some embodiments, the knob 191 isremovably coupled to the threaded rod 194. In some embodiments, the knob191 is coupled to a proximal end of the threaded rod 194. In someembodiments, the collar 196 is coupled to the threaded rod 194. In someembodiments, the collar 196 is coupled to the threaded rod 194 by afastener, an adhesive, a pin 197, welding or any combination thereof. Insome embodiments, the spinner 192 is positioned between the knob 191 andthe collar 196. In some embodiments, the spinner 192 comprises anaperture accepting the threaded rod 194. In some embodiments, thespinner 192 further comprises a terminator channel 192A accepting thecoupled ends of one or more suture strands 130. In some embodiments, thespinner 192 further comprises a terminator channel 192A accepting theterminator of the suture strand 130. In some embodiments, the spinner192 comprises 1, 2, 3, 4, 5, 6, or more terminator channels 192A. Insome embodiments, the handle 193 comprises a cavity, wherein at least aportion of the cavity comprises a threaded feature configured to coupleto the threaded rod 194. In some embodiments, a distal portion of thehandle 193 comprises a tensioning feature 195A configured to rotate thedriver feature of the lock 140. In some embodiments, the knob 191 iscoupled to the proximal end of the threaded rod 194 by a pin 197, anadhesive, a fastener, a press-fit, a weld, or any combination thereof.As shown, the collar 196 is coupled to the threaded rod 194 by afastener. Alternatively, in some embodiments, the collar 196 is coupledto the threaded rod 194 by a pin, an adhesive, a press-fit, a weld, orany combination thereof. In some embodiments, the lock 140 furthercomprises the alignment feature 143, and wherein the distal portion ofthe handle 193 further comprises a tensioning alignment feature 195Bthat couples to the alignment feature 143. In some embodiments, rotatingthe knob 191 and the threaded rod 194 in a first direction with respectwith to the handle 193 translates the knob 191 and the spinner distallywith respect to the handle 193. In some embodiments, rotating the knob191 and the threaded rod 194 in a second direction opposite the firstdirection translates the knob 191 and the spinner proximally withrespect to the handle 193. In some embodiments, the knob 191 is rotatedto translate the spinner 192 proximally or distally, so as to obtain adesired tension of suture strands 130 that are coupled to a terminatorchannel 192A. In some embodiments, rotating the handle 193 in a firstdirection inserts the secondary threaded portion 141 of the lock 140distally through the primary threaded portion 113 of the primary button110. In some embodiments, rotating the handle 193 in a second directionopposite the first direction translates the secondary threaded portion141 of the lock 140 proximally through the primary threaded portion 113of the primary button 110. In some embodiments, the tightening tool 190enables a greater tightening force than can be applied by hand. In someembodiments, the tightening tool 190 enables a more precise and tunabletightening force than can be applied by hand.

In some embodiments, applying tension between two ends of each of theone or more suture strands 130 reduces a distance between the primarybutton 110 and the secondary button 120. In some embodiments, applyingtension between two ends of each of the one or more suture strands 130reduces a distance between the distal surface of the primary button 110and a proximal surface of the secondary button 110. In some embodiments,applying tension between two ends of each of the one or more suturestrands 130 provides a clamping force between the distal surface of theprimary button 110 and a proximal surface of the secondary button 110.In some embodiments, applying tension between two ends of each of theone or more suture strands 130 increases a clamping pressure that theprimary button 110 and the secondary button 110 apply to a target tissuetherebetween. In some embodiments, applying tension between two ends ofeach of the one or more suture strands 130 increases a clamping pressurethat the distal surface of the primary button 110 and the proximalsurface secondary button 110 apply to a target tissue therebetween.

In some embodiments, the target tissue comprises two or more portions ofa bone, a muscle tissue, an epithelial tissue, a connective, tissue, anervous tissue, or any combination thereof. In some embodiments, two ormore of the following are clamped together between the primary button110 and the secondary button 110: a bone, a muscle tissue, an epithelialtissue, a connective, tissue, a nervous tissue, or any combinationthereof. In some embodiments, upon tensioning of the suture strands 130,the primary button 110 and the secondary button 120 clamp a bone to:another bone, a muscle tissue, an epithelial tissue, a connective,tissue, a nervous tissue, or any combination thereof. In someembodiments, upon tensioning of the suture strands 130, the primarybutton 110 and the secondary button 120 clamp a muscle tissue to: bone,another muscle tissue, an epithelial tissue, a connective, tissue, anervous tissue, or any combination thereof. In some embodiments, upontensioning of the suture strands 130, the primary button 110 and thesecondary button 120 clamp an epithelial tissue to: bone, muscle tissue,another epithelial tissue, a connective, tissue, a nervous tissue, orany combination thereof. In some embodiments, upon tensioning of thesuture strands 130, the primary button 110 and the secondary button 120clamp a connective tissue to: bone, muscle tissue, epithelial tissue,another connective, tissue, a nervous tissue, or any combinationthereof. In some embodiments, upon tensioning of the suture strands 130,the primary button 110 and the secondary button 120 clamp a nervoustissue to: bone, muscle tissue, epithelial tissue, connective, tissue,another nervous tissue, or any combination thereof.

Suture-Button Assemblies

Another aspect provided herein, per FIGS. 23-26B, is a suture-buttonassembly 200 comprising two suture-button systems 100 and an insertionplate 150. In some embodiments, the suture button assembly 200 comprises2, 3, 4, 5, 6, or more suture button systems 100. As shown, theinsertion plate 150 comprises two insertion plate apertures 151, whereineach insertion plate aperture 151 accepts at least one suture strand.Alternatively, in some embodiments, each insertion plate apertures 151accepts the sutures of 1, 2, 3, 4, 5, 6 or more suture buttonassemblies. In some embodiments, the plurality of insertion plateapertures 151 comprises 2, 3, 4, 5, 6, or more insertion plate apertures151, wherein each insertion plate aperture 151 accepts the sutures ofone suture button assembly. In some embodiments, each insertion plateapertures 151 accepts 1, 2, 3, 4, 5, 6 or more sutures. In someembodiments, the plurality of insertion plate apertures 151 In someembodiments, a screw hole 152 is positioned between two of the pluralityof insertion plate apertures 151. In some embodiments, the screw hole152 is positioned equidistant between two of the plurality of insertionplate apertures 151.

In some embodiments, the assembly further comprises an insertion screw160. In some embodiments, insertion screw 160 is configured to beremovably coupled with the screw hole 152. In some embodiments, theinsertion screw 160 comprises a first portion 161, a second portion 162configured to attach to a bone of a patient, and a third portion 163having length and/or diameter greater than a greatest length or diameterof the screw hole 152. In some embodiments, the third portion 163prevents the first portion 161 from passing through the screw hole 152after the second portion 162 has been inserted therethrough. In someembodiments, the second portion comprises a threaded feature configuredto attach to the bone of the patient.

Method of Assembling a First Suture Button System

Another aspect provided herein is a method of assembling a first suturebutton system 100. In some embodiments, the method comprises: providinga first suture-button system 100 wherein the primary button 110comprises a first primary aperture 111 and a second primary aperture111, wherein the secondary button 120 comprises a first secondaryaperture 121 and a second secondary aperture 121, and wherein the firstsuture button system comprises one suture strand 130. In someembodiments, the method comprises inserting the suture strand 130through the first primary aperture 111, inserting the one suture strand130 through the first secondary aperture 121, inserting the one suturestrand 130 through the second secondary aperture 121, and inserting theone suture strand 130 through the second primary aperture 111. In someembodiments, one or more of the steps of inserting the suture strand 130through the first primary aperture 111, through the first secondaryaperture 121, through the second secondary aperture 121, and through thesecond primary aperture 111 are performed simultaneously. In someembodiments, the method further comprises coupling the two ends of thesuture strand 130 together. In some embodiments, the method furthercomprises coupling the two ends of the suture strand 130 by tying thetwo ends of the suture strand 130 together. In some embodiments, themethod further comprises coupling the two ends of the suture strand 130with a terminator.

In some embodiments, the method further comprises inserting thesecondary button 120 through a hole in a proximal surface of a bone ortissue of a patient, and tightening the suture such that the primarybutton 110 and the secondary button 120 are tightly pressed againstopposing surfaces of the bone. In some embodiments, the secondary button120 is inserted through a bone or tissue hole extending through at leastone bone. In some embodiments, the bone or tissue hole is a tunnel,channel, passageway, or any combination thereof. In some embodiments,the secondary button 120 is attached to an insertion needle 220 via oneor more insertion suture 210 loops. In some embodiments, the insertionsuture 210 loops may be formed by passing an insertion suture 210through one or more secondary apertures 121 in the secondary button 120and attaching both free ends of the one or more insertion suture strands210 to the insertion needle 220. In some embodiments, the free ends ofthe one or more insertion suture strands 210 are attached to theinsertion needle 220 via crimping. In some embodiments, the insertionneedle 220 may be inserted through said bone or tissue hole on a firstside of the bone or tissue, and received on a second side, such that thesecondary button 120 is pulled through the hole in its most narrowconfiguration. In some embodiments, the secondary button 120, afterpassing through the bone or tissue hole in its most narrowconfiguration, is then pivoted such that it lies flat against the boneor tissue. In some embodiments, the secondary button 120 lies againstthe bone or tissue on its length 120A. In some embodiments, the primarybutton 110 and secondary button 120 are disposed on either side of thebone or tissue hole with the suture 130 extending through the bone ortissue hole. In some embodiments, the insertion needle 220 isdisconnected from the secondary button by cutting and removing theinsertion suture 210. In some embodiments, the suture strand 130 istightened, such that the primary and secondary buttons apply a clampingforce or pressure on a first and second side of a bone or tissue.

As described herein, tightening the suture includes applying a tensionto the coupled ends of the suture 130. In some embodiments, pulling thecoupled ends of the suture 130 applies tension to the suture. In someembodiments, pulling the coupled ends of the suture 130 in a proximaldirection applies tension to the suture. In some embodiments, thetightening is performed by hand. In some embodiments, the tightening isperformed by the lock driver described herein. In some embodiments, thetightening is performed by rotating the tightening tool 190 herein. Insome embodiments, the tightening comprises inserting the suture strandloop 130 within the terminator channels 192A of the spinner 192,coupling the tensioning feature 195A and the driver feature of the lock140, and rotating the knob 191 with respect to the handle 193. In someembodiments, the tightening comprises inserting the suture strand loop130 within the terminator channels 192A of the spinner 192, coupling thetensioning feature 195A and the driver feature of the lock 140, rotatingthe knob 191 with respect to the handle 193, and rotating the tighteningtool 190 with respect to the driving feature of the lock 140. In someembodiments, rotating the knob 191 in a first direction translates thespinner 192 and terminator channels 192A proximally from the handle 193,thereby tightening the suture strand 130. In some embodiments, rotatingthe knob 191 in a second direction translates the spinner 192 andterminator channels 192A distally to the handle 193, thereby looseningthe suture strand 130, and decreasing the tension. In some embodiments,once the desired tension is reached the lock 140 is tightened againstthe primary button 110 such that the suture is locked in placetherebetween. In some embodiments, the lock 140 is loosened against theprimary button 110 to enable readjustment of the tension of the suturestrand, wherein the lock 140 is subsequently tightened against theprimary button 110 once the desired tension is reached. In someembodiments, the method further comprises trimming the loose ends of thesuture.

Method of Assembling a Second Suture Button System

Further provided herein, per FIGS. 27A-29B, is a method of assembling asecond suture button system 100. In some embodiments, the methodcomprises providing a second suture-button system 100 wherein theprimary button 110 comprises a first primary aperture 111, a secondprimary aperture 111, a third primary aperture 111, and a fourth primaryaperture 111, the secondary button 120 comprises a first secondaryaperture 121 and a second secondary aperture 121, and the one or more asuture strands 130 consists of a first suture strand 130 and a secondsuture strand 130.

In some embodiments, the method comprises: inserting the first suturestrand 130 through the first primary aperture 111; inserting the firstsuture strand 130 through the first secondary aperture 121; insertingthe first suture strand 130 through the second secondary aperture 121;inserting the first suture strand 130 through the second primaryaperture 111; inserting the second suture strand 130 through the thirdprimary aperture 111; inserting the second suture strand 130 through thefirst secondary aperture 121; inserting the second suture strand 130through the second secondary aperture 121; and inserting the secondsuture strand 130 through the fourth primary aperture 111. In someembodiments, one or more of the inserting the first suture strand 130through the first primary aperture 111, inserting the first suturestrand 130 through the first secondary aperture 121, inserting the firstsuture strand 130 through the second secondary aperture 121, insertingthe first suture strand 130 through the second primary aperture 111,inserting the second suture strand 130 through the third primaryaperture 111, inserting the second suture strand 130 through the firstsecondary aperture 121, inserting the second suture strand 130 throughthe second secondary aperture 121, and inserting the second suturestrand 130 through the fourth primary aperture 111 are performedsimultaneously.

In some embodiments, the method comprises: inserting the first suturestrand 130 through the first primary aperture 111; inserting the firstsuture strand 130 through the first secondary aperture 121; insertingthe first suture strand 130 through the second secondary aperture 121;inserting the first suture strand 130 through the second primaryaperture 111; inserting the second suture strand 130 through the thirdprimary aperture 111; inserting the second suture strand 130 through thesecond secondary aperture 121; inserting the second suture strand 130through the first secondary aperture 121; and inserting the secondsuture strand 130 through the fourth primary aperture 111. In someembodiments, one or more of the inserting the first suture strand 130through the first primary aperture 111, inserting the first suturestrand 130 through the first secondary aperture 121, inserting the firstsuture strand 130 through the second secondary aperture 121, insertingthe first suture strand 130 through the second primary aperture 111,inserting the second suture strand 130 through the third primaryaperture 111, inserting the second suture strand 130 through the secondsecondary aperture 121, inserting the second suture strand 130 throughthe first secondary aperture 121, and inserting the second suture strand130 through the fourth primary aperture 111 are performedsimultaneously.

Per FIG. 29A, both the first primary aperture 111 and the third primaryaperture 111 are adjacent to the second primary aperture 111 and thefourth primary aperture 111. Further as shown, the first primaryaperture 111, the second primary aperture 111, the third primaryaperture 111 and the fourth primary aperture 111 are arrayedsequentially in a clockwise direction about the primary button 110.Alternatively, in some embodiments, both the first primary aperture 111and the second primary aperture 111 are adjacent to the third primaryaperture 111 and the fourth primary aperture 111. In some embodiments,the first primary aperture 111, the third primary aperture 111, thesecond primary aperture 111 and the fourth primary aperture 111 arearrayed sequentially in a clockwise direction about the primary button110. In some embodiments, the first primary aperture 111, the thirdprimary aperture 111, the second primary aperture 111 and the fourthprimary aperture 111 are arrayed sequentially in a counter-clockwisedirection about the primary button 110. In some embodiments, the firstprimary aperture 111, the second primary aperture 111, the third primaryaperture 111 and the fourth primary aperture 111 are arrayedsequentially in a counter-clockwise direction about the primary button110.

In some embodiments, the method further comprises inserting thesecondary button 120 through a hole in a bone or tissue of a patient, asdescribed herein, and tightening the sutures such that the primarybutton 110 and the secondary button 120 are tightly pressed againstrespective surfaces of the bone or tissue. In some embodiments, thetightening is performed by hand. In some embodiments, the tightening isperformed by the lock driver as described herein. In some embodiments,the tightening is performed by the tightening tool as described herein.

In some embodiments, once the desired tension is reached, the lock 140is tightened against the primary button 110 such that the sutures arelocked in place therebetween. In some embodiments, the method furthercomprises trimming the loose ends of the sutures.

Method of Assembling a Suture Button Assembly

Provided herein, per FIGS. 23-26B are methods for assembling a suturebutton assembly 200. In some embodiments, the method comprises insertingthe primary button 110 of a first suture button system 100 into a firstinsertion plate aperture 151 of the insertion plate 150, and insertingthe primary button 110 of a second suture button system 100 into asecond insertion plate aperture 151 of the insertion plate 150. In someembodiments, the method comprises inserting the secondary button 120 ofa first suture button system 100 into a first insertion plate aperture151 of the insertion plate 150, and inserting the secondary button 120of a second suture button system 100 into a second insertion plateaperture 151 of the insertion plate 150. In some embodiments, the methodcomprises inserting the primary button 110 of a first suture buttonsystem 100 into a first insertion plate aperture 151 of the insertionplate 150, and inserting the secondary button 120 of a second suturebutton system 100 into a second insertion plate aperture 151 of theinsertion plate 150.

In some embodiments, the method comprises inserting each of a pluralityof suture strands 130 through one or more of the secondary apertures 121of the secondary button 120 of a first suture button system 100,inserting each of a plurality of suture strands 130 through one or moreof the secondary apertures 121 of the secondary button 120 of a secondsuture button system 100, inserting each of a plurality of suturestrands 130 of the first suture button system 100 through a firstinsertion plate aperture 151 of the insertion plate 150, inserting eachof a plurality of suture strands 130 of the second suture button system100 through a second insertion plate aperture 151 of the insertion plate150, inserting each of a plurality of suture strands 130 through one ormore of the primary apertures 111 of the primary button 110 of a firstsuture button system 100, and inserting each of a plurality of suturestrands 130 through one or more of the primary apertures 111 of theprimary button 110 of a second suture button system 100.

In some embodiments, the method further comprises inserting theinsertion screw 160 into the insertion hole 152 of the insertion plate150. In some embodiments, the method further comprises screwing theinsertion screw 160 into a bone or tissue of a patient. In someembodiments, screwing the insertion screw 160 into a bone or tissue of apatient temporarily fixates the plate to the bone or tissue of thepatient while the suture-button system is deployed.

Terms and Definitions

Unless otherwise defined, all technical terms used herein have the samemeaning as commonly understood by one of ordinary skill in the art towhich this disclosure belongs.

As used herein, the singular forms “a,” “an,” and “the” include pluralreferences unless the context clearly dictates otherwise. Any referenceto “or” herein is intended to encompass “and/or” unless otherwisestated.

As used herein, the term “about” in some cases refers to an amount thatis approximately the stated amount.

As used herein, the term “about” refers to an amount that is near thestated amount by 10%, 5%, or 1%, including increments therein.

As used herein, the term “about” in reference to a percentage refers toan amount that is greater or less the stated percentage by 10%, 5%, or1%, including increments therein.

As used herein, the term “generally” refers to a geometric relationshipbetween two or more elements within tolerances of 10%, 5%, or 1%,including increments therein.

As used herein, the phrases “at least one”, “one or more”, and “and/or”are open-ended expressions that are both conjunctive and disjunctive inoperation. For example, each of the expressions “at least one of A, Band C”, “at least one of A, B, or C”, “one or more of A, B, and C”, “oneor more of A, B, or C” and “A, B, and/or C” means A alone, B alone, Calone, A and B together, A and C together, B and C together, or A, B andC together.

EXAMPLES

The following illustrative examples are representative of embodiments ofthe systems, and methods described herein and are not meant to belimiting in any way.

Example 1—Syndesmosis Repair

In one example of an ankle syndesmosis repair, suture-button assembly isused, wherein the secondary button rests on the tibia and the primarybutton rests on the fibula. The plate of the suture-button assembly isplaced on the fibula across a fracture, so that one suture-button systemis deployed on either side of the fracture. The insertion screw is usedto temporarily fixate the plate to the fibula while the suture-buttonsystem is deployed.

While preferred embodiments of the present disclosure have been shownand described herein, it will be obvious to those skilled in the artthat such embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the disclosure. It should beunderstood that various alternatives to the embodiments of thedisclosure described herein may be employed in practicing thedisclosure.

What is claimed is:
 1. A suture-button system comprising: (a) aplurality of suture strands; (b) a primary button having a plurality ofprimary apertures and a primary threaded portion, wherein a proximalface of the primary button comprises a countersink, wherein: (i) a firstsuture strand of the plurality of suture strands is inserted through afirst set of the plurality of primary apertures; and (ii) a secondsuture strand of the plurality of suture strands is inserted through asecond set of the plurality of primary apertures; and (iii) the firstset is different from the second set; (c) a secondary button having aplurality of secondary apertures, wherein: (i) the first suture strandand the second suture strand are each inserted through a first andsecond secondary aperture of the plurality of secondary apertures, suchthat the system is configured to have at least one targeted tissue of asubject to be clamped between a distal surface of the primary button anda proximal surface of the secondary button upon applying a tension toone or both of the first suture strand and the second suture strand; and(d) a lock having a secondary threaded portion, wherein the secondarythreaded portion is configured to be removably coupled to the primarythreaded portion, wherein coupling the secondary threaded portion of thelock to the primary threaded portion prevents one or both of the firstsuture strand and the second suture strand from translating through theplurality of primary apertures, thereby configured to secure theclamping of the targeted tissue, wherein at least a portion of the lockextends beyond a distal face of the primary button when the primarybutton is coupled to the lock.
 2. The system of claim 1, wherein theplurality of primary apertures comprises at least 4 primary apertures.3. The system of claim 1, wherein the plurality of primary apertures areequally spaced on the primary button.
 4. The system of claim 1, whereinthe first set of primary apertures are equally spaced relative to eachother and in at least a partially circular array about the primarythreaded portion, and the second set of primary apertures are equallyspaced relative to each other and in at least a partially circular arrayabout the primary threaded portion.
 5. The system of claim 1, whereinthe primary threaded portion comprises a female threaded portion.
 6. Thesystem of claim 1, wherein a distal surface of the secondary buttoncomprises a channel connecting two or more of the plurality of secondaryapertures.
 7. The system of claim 1, wherein an aspect ratio between alength and width of the secondary button is about 1:1 to about 4:1. 8.The system of claim 1, wherein the lock comprises a head and wherein thesecondary threaded portion extends from the head.
 9. The system of claim8, wherein a distal surface of the head is tapered outwards from acenter axis of the lock.
 10. The system of claim 9, wherein the distalsurface of the head is tapered outwards from the center axis of the lockby about 20° to about 89°.
 11. The system of claim 1, wherein the lockcomprises a driver feature, an alignment feature, or both.
 12. Thesystem of claim 11, wherein the driver feature and the alignment featureare generally concentric.
 13. The system of claim 11, wherein the driverfeature is proximal to the alignment feature.
 14. The system of claim13, wherein a maximum inner diameter of the driver feature is greaterthan a maximum inner diameter of the alignment feature.
 15. The systemof claim 1, wherein the first suture strand or the second suture strandis a #1 size suture, a #2 size suture, a #3 size suture, a #4 sizesuture, a #5 size suture, a #6 size suture, or a #7 size suture.
 16. Thesystem of claim 1, wherein the first suture strand or the second suturestrand has a length of about 100 mm to about 1,200 mm.
 17. The system ofclaim 1, wherein the plurality of suture strands comprises 3, 4, 5, 6 ormore suture strands.
 18. A method of securing one or more sutures, themethod comprising: (a) providing a suture-button system comprising: (i)a first suture strand and a second suture strand, (ii) a primary buttonhaving a first set of primary apertures and a second set of primaryapertures, wherein the first set is different from the second set,wherein a proximal face of the primary button comprises a countersink,and wherein the primary button has a primary threaded portion (iii) asecondary button having a first secondary aperture and a secondsecondary aperture, and (iv) a lock having a secondary threaded portion,wherein the secondary threaded portion is configured to be removablycoupled to the primary threaded portion, wherein coupling the secondarythreaded portion of the lock to the primary threaded portion preventsone or both of the first suture strand and the second suture strand fromtranslating through the first set and the second set, wherein at least aportion of the lock extends beyond a distal face of the primary buttonwhen the primary button is coupled to the lock; (b) inserting the firstsuture strand and the second suture strand each through the firstsecondary aperture and the second secondary aperture, (c) inserting thefirst suture strand through a first primary aperture and a secondprimary aperture of the first set; and (d) inserting the second suturestrand through a first primary aperture and a second primary aperture ofthe second set.
 19. The method of claim 18, further comprising insertingthe secondary button through a hole in a bone or tissue.
 20. The methodof claim 19, further comprising rotating the secondary button after itsinsertion through the hole in the bone or tissue such that a proximalface of the secondary button lies against the bone or tissue.
 21. Themethod of claim 20, further comprising tightening one or both of thefirst suture strand and the second suture strand with respect to theprimary button, the secondary button, or both, such that the bone ortissue is clamped between a distal surface of the primary button and theproximal surface of the secondary button upon applying a tension to oneor both of the first suture strand and the second suture strand.
 22. Themethod of claim 18, wherein an aspect ratio between a length and widthof the secondary button is about 1:1 to about 4:1.
 23. The method ofclaim 18, further comprising coupling the secondary threaded portion ofthe lock with the primary threaded portion of the primary button. 24.The method of claim 18, wherein (b)-(d) occurs in any sequential order.25. The method of claim 18, wherein the first set of primary aperturesare equally spaced relative to each other and in at least a partiallycircular array about the primary threaded portion of the primary button,and the second set of primary apertures are equally spaced relative toeach other and in at least a partially circular array about the primarythreaded portion.